Handheld Diagnostic Device Integrating Smartphone Algorithms

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Solution Overview

Problem

Existing rapid diagnostic tests are limited by complexity, requiring medical interpretation and IT infrastructure, making them inaccessible for point-of-care use outside laboratories and hospitals, and lacking the ability to perform quantitative and qualitative tests without complex equipment.

Innovation Solution

A handheld diagnostic test device that integrates with electronic devices like smartphones, enabling rapid diagnostic tests using a test cartridge with onboard sensors and algorithms for data processing and presentation, allowing for quantitative and qualitative results without the need for extensive IT infrastructure or medical expertise.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If sophisticated and accurate rapid point-of-care tests are implemented, then diagnostic accuracy is improved, but device complexity increases making them inaccessible outside laboratories and hospitals

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidtest device complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple functions (sensing, data processing, result presentation, and electronic device integration) into a single handheld diagnostic device. The sensor array detects test results while onboard algorithms process the data and generate presentable outputs, eliminating the need for separate complex laboratory equipment and making accurate diagnostics portable and accessible at point-of-care settings.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The handheld device is designed to perform multiple diagnostic functions using a single integrated platform. It can interface with various electronic devices (smartphones, tablets, computers) and process different types of test data through universal algorithms, allowing one device to replace multiple specialized laboratory instruments while maintaining diagnostic accuracy.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Extent of automation

If automated data recordal and electronic medical record integration are implemented, then data management capability is improved, but requirement for IT infrastructure increases

Engineering Contradiction:
Improveautomated data recordalVSAvoidIT infrastructure requirement
Core Design Contradiction:
Extent of automationVSDevice complexity

Solution Approach 1:

The handheld device acts as an intermediary between the test cartridge and electronic medical records systems. It automatically captures test data through sensors, processes the information locally using onboard algorithms, and then transmits results to electronic devices for EMR integration. This intermediary approach enables automated data recordal without requiring complex centralized IT infrastructure at the point-of-care location.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The device performs self-service data processing by automatically capturing test results through sensors, analyzing the data using onboard algorithms, and generating presentable outputs without requiring manual data entry or complex external processing systems. This automation reduces the burden on IT infrastructure while maintaining comprehensive data management capabilities.

Inventive Principle:
Principle #25Self-service

3Ease of operation

If quantitative and qualitative diagnostic tests are performed without laboratory equipment, then portability is improved, but measurement precision may be compromised

Engineering Contradiction:
ImproveportabilityVSAvoidquantitative test accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent replaces complex mechanical and optical laboratory measurement systems with electronic sensors and digital signal processing. The sensor array detects test results electronically, and onboard algorithms process the signals to generate accurate quantitative and qualitative results. This substitution of mechanical systems with electronic ones maintains measurement precision while enabling portability and eliminating the need for bulky laboratory equipment.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables accurate and sensitive diagnostic testing at the point of care with minimal technical knowledge, providing results comparable to laboratory settings while being portable and user-friendly, facilitating infectious disease surveillance and emergency medical response.

Implementation Method 1

one or more sensors for operative detection of test data from the sample after reaction with the reagents

Methodology Applied
Scientific EffectSensor detection:

Data Source

PatentUS11385219B2Handheld diagnostic test device and method for use with an electronic device and a test cartridge in a rapid diagnostic test
Publication Date: 2022.07.12 FIO CORP
  • US11385219B2 patent drawing
  • US11385219B2 patent drawing
  • US11385219B2 patent drawing

AI summary

A handheld diagnostic test device includes a port to removably receive a test cartridge, an element connected with an electronic device, and sensors for detection of test data from a biological or environment sample after reaction with reagents onboard the cartridge. The test device also includes memory storing algorithms for upload to the electronic device to enable a processor thereof: to await elapse of a pre-determined time following reaction of the sample with the reagents; to thereafter instruct the sensors to detect the test data; to generate presentation data based on the test data; and to present the presentation data from a presentation element of the electronic device to a user. A related method includes a connecting step, an uploading step, a presentation step, a cartridge inserting step, a waiting step, a sensing step, and an electronic device processing step.